The first sublingual therapy for the on-demand treatment of OFF episodes in Parkinson’s disease
BIAL, a hundred-year-old innovation-driven biopharmaceutical company focused on neurology, today announced the launch of KYNMOBI® (apomorphine hydrochloride), the first and only sublingual film approved in Germany, for the intermittent treatment of OFF episodes in adult patients with Parkinson’s disease who are not sufficiently controlled by oral anti-Parkinson medication. This launch follows the Marketing Authorization issued by BfArM on March 9th, 2023.
KYNMOBI® (apomorphine hydrochloride) is the first and only sublingual (under the tongue) film commercialized for the on-demand treatment of OFF episodes. In Germany, approximately 260,000 people live with Parkinson's disease.1
Apomorphine hydrochloride sublingual film is a novel formulation of apomorphine, a non-ergoline dopamine agonist, that dissolves under the tongue for the acute, on-demand treatment of OFF episodes associated with Parkinson’s disease.2 Apomorphine hydrochloride sublingual film provides a novel, generally well-tolerated, effective, on-demand therapy for OFF periods and motor fluctuations in Parkinson’s disease.
Prof. Alexander Storch, Department of Neurology of the University Medical Center Rostock, commented, "Despite the availability of medical and surgical treatments, many people living with Parkinson’s disease, experience troubling and unpredictable OFF episodes, demand therapies to help them self-manage OFF aimed at reducing daily OFF time. Given the urgent need for an easy-to-administer, effective, and well-tolerated on-demand therapy for OFF periods, the launch of the apomorphine sublingual film may provide an exciting alternative for the German Parkinson’s disease community.”
Parkinson’s disease affects everyone differently and most experience ON and OFF episodes. ONs are the periods during which the patient responds to medication and experiences satisfactory improvement in motor and non-motor symptoms. OFF episodes occur when the patient experiences changes in their clinical state, i.e. motor and/or non-motor symptoms may reappear or worsen.3,4
OFF episodes can manifest as parkinsonism with tremor, rigidity, bradykinesia, gait impairment, and falling, in addition to non-motor symptoms.5 Fifty percent of patients will experience OFF episodes after 5 years of oral levodopa treatment.6 Following 10 years of oral levodopa treatment, nearly 100% of patients will experience OFF episodes.7 Treatments for Parkinson’s disease predominantly focus on controlling the motor symptoms of the disease to reduce tremors, stiffness, and slowness.7
“Reduced mobility associated with OFF episodes represents a substantial burden for nearly all people living with Parkinson’s disease. Disruption to everyday activities such as using the bathroom, changing clothes, and feeding can often be a challenge when experiencing these episodes, and the difficulties may intensify as Parkinson’s disease progresses and OFF episodes become more frequent. KYNMOBI® brings us an important step closer to being able to provide a quick and reliable transition from OFF to ON so eligible patients can more easily function in their daily lives. At BIAL, creating value for patients so they can live more on their terms is our major pledge to people living with Parkinson’s disease and their families.”, said Max Bricchi, Executive Vice President, Chief Commercial Officer of BIAL.
The commercialization of KYNMOBI® (apomorphine hydrochloride) sublingual film in Germany follows a decentralized approval process in Europe. BIAL announced in September 2021 an agreement with Sumitomo Pharma America, Inc. (SMPA) whereby BIAL received exclusive commercial license rights to commercialize apomorphine hydrochloride sublingual film in the European Union, the European Economic Area, and the United Kingdom.
BIAL is committed to expanding treatment options for people with Parkinson’s disease in Europe and helping patients cope with the difficult and disabling symptoms of OFF episodes and anticipates additional EU launches of apomorphine hydrochloride sublingual film over the coming year.
Parkinson’s disease is the most common neurodegenerative movement disorder in Europe.8 According to the European Parkinson’s Disease Association (EPDA) around 6.3 million people have Parkinson’s disease worldwide. Along with available statistics, 1.2 million people in the European Union have Parkinson’s disease, approximately 260,000 in Germany, which is expected to double by 2030.1
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About KYNMOBI® Apomorphine Sublingual Film:
Apomorphine hydrochloride sublingual film is a sublingual formulation of apomorphine, a non-ergoline dopamine agonist for the intermittent treatment of OFF episodes in patients with Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication. KYNMOBI® may be used up to five times a day. Phase 3 clinical trial results, published in Lancet Neurology, demonstrated that patients with PD receiving apomorphine sublingual film experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.
Separation from placebo was seen as early as 15 minutes post-dose (first-time point measured) and persisted up to 90 minutes (last time point measured). Additionally, a significantly higher percentage of people treated with apomorphine sublingual film had a patient-rated full ON response within 30 minutes at week 12, compared with people receiving a placebo. Apomorphine sublingual film was generally well-tolerated. Among the most frequently reported treatment-emergent adverse events in this study
(occurring in more than 5 percent of patients and at a rate greater than placebo) were nausea, oropharyngeal reactions, somnolence, and dizziness.
References
1. Age Platform. Let’s Talk About Parkinson’s. Available at: https://www.age-platform.eu/sites/default/files/EPDA-Political_Manifesto_Parkinson.pdf. (Accessed Feb. 2024)
2. KYNMOBI® (apomorphine hydrochloride) EU Summary of Product Characteristics, 2023.
3. Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease (2009). Neurology. 2009;72(21 Suppl 4):S1-136.
4. Chou KL, Stacy M, Simuni T, et al. The spectrum of “off” in Parkinson’s disease: what have we learned over 40 years? Parkinsonism Relat Disord. 2018;51:9-16.
5. Olanow CW, Factor SA, Espay AJ, Hauser RA, Shill HA, Isaacson S, Pahwa R, Leinonen M, Bhargava P, Sciarappa K, Navia B, Blum D; CTH-300 Study investigators. Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study. Lancet Neurol. 2020 Feb;19(2):135-144. doi: 10.1016/S1474-4422(19)30396-5. Epub 2019 Dec 7. PMID: 31818699
6. Tanner CM. Exploring the clinical burden of OFF periods in Parkinson disease. Am J Manag Care. 2020;26:S255–64.
7. ClinicalTrialsArena. KYNMOBI for the treatment of OFF episodes in Parkinson’s Disease, USA. 16 September 2022. Clin Trials Arena. Available at: https://www.clinicaltrialsarena.com/projects/kynmobi-for-the-treatment-of-off-episodes-in-parkinsons-disease/ (Accessed Feb. 2024).
8. Balestrino, R. and Schapira, A. (2020), Parkinson disease. Eur J Neurol, 27: 27-4 "https://doi.org/10.1111/ene.1410
